Azur CX Detachable recallZ-0187-2024 · Microvention Inc. · initiated Aug 24, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microvention Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Peripheral coil system detachable has a potential of unsealed pouch packaging.
FDA root cause category: Process control
What the company is doing
On 8/22/23, recall notices were mailed to customers, who were asked to do the following: 1) Stop using, quarantine, and return affected devices to the firm. 2) Complete and return the customer acknowledgement form via email to [email protected]. Inquires can be directed to customer service at 800-990-8368
Recall details
- Recall number
- Z-0187-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 24, 2023
- Posted by the FDA
- Oct 27, 2023
- Recalling firm
- Microvention Inc.
- Quantity
- 14
- Product code
- KRD
- FDA submissions
- K151358
- Distribution
- US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Product description
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Code information (models, lots, serial numbers)
UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Azur CX Detachable 45-751324Microvention, Inc. · Device, Vascular, for Promoting Embolization1 recall42 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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